Abbott Receives FDA Clearance for its Imaging Technology Using Artificial Intelligence for Vessels in the Heart


- Ultreon™ 1.0 Software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using Artificial Intelligence
- The new intuitive interface provides step-by-step guidance to enhance ease of use
- When combined with Abbott's Dragonfly OpStar™ imaging catheter and PressureWire X™, the platform provides physicians with a comprehensive set of tools to provide better patient care


ABBOTT PARK, Ill., Aug. 3, 2021 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it has received U.S. Food and Drug Administration (FDA) clearance for its latest optical coherence tomography (OCT) imaging platform powered by the company's new Ultreon Software. This innovative imaging software combines OCT with artificial intelligence (AI) to provide physicians an enhanced, comprehensive view of coronary blood flow and blockages to assist physician decision-making and provide the best pathway for treatment.

U.S. clearance follows the recently attained CE Mark in Europe, providing broader access to the latest OCT imaging platform for interventional cardiologists seeking to utilize the latest in AI-powered technology. Ultreon Software integrates with Abbott's new Dragonfly OpStar imaging catheter and PressureWire X guidewire to provide physicians access to a broad set of tools to assess coronary blood flow and blockages and improve treatment planning for patients.   

"Abbott's new Ultreon Software for OCT provides an automated, comprehensive view of the artery that facilitates physician decision-making," said Ziad Ali, M.D.D.Phil, director of the DeMatteis Cardiovascular Institute at St. Francis Hospital and Heart Center in New York. "Ultreon Software guides stents to be placed with precision. These types of innovative technologies are instrumental in providing the best care for our patients."

Earlier this year, an annual study by Abbott titled Beyond Intervention revealed that physicians view forward-thinking and innovative technologies as critical components to providing the best patient care. According to the research, 83.2% of physicians agreed that advances in diagnostic and treatment technologies, such as OCT, have translated to tangible improvements in patient care.1

"As cardiologists continue to adopt OCT and move away from traditional imaging methods such as angiography, emerging technologies are pivotal to determine the best course of patient care," said Nick West, M.D., chief medical officer and divisional vice president of global medical affairs at Abbott's vascular business. "AI enables Ultreon Software to automatically detect calcium and vessel diameters allowing doctors to put stents exactly where they are needed."

The launch of Ultreon Software for OCT in the United States demonstrates Abbott's commitment to continual innovation in the global vascular community with the latest medical devices and technologies. For example, recent data shows that when OCT is paired with Abbott's MLD MAX, a new workflow that helps guide and optimize stenting decisions, physicians have altered their treatment strategy in treating 88% of coronary artery blockages.2 Abbott's latest technologies play a vital role in improving cardiovascular patient care and achieving optimal outcomes during and after intervention. For U.S. important safety information on Ultreon, visit:

Abbott showcased Ultreon Software for the first time at EuroPCR 2021 and recently received approval in Japan.

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Connect with us at, on LinkedIn at, on Facebook at and on Twitter @AbbottNews.


Cision View original content:


Company Codes: NYSE:ABT

Back to news